Clearance Summary
BioHealx Anal Fistula Device received FDA 510(k) clearance under submission number DEN240007, sponsored by Signum Surgical Limited. The device was reviewed via the Direct premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2024-07-01.
- Submission: DEN240007
- Applicant / Sponsor: Signum Surgical Limited
- Clearance pathway: Direct
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4835
- Decision date: 2024-07-01
Classification & Regulation
This clearance is catalogued under FDA product code QML and 21 CFR 878.4835, within the General, Plastic Surgery review panel as a Class II device.